GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)
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ClinicalTrials.gov Identifier: NCT01813422 |
Recruitment Status
:
Completed
First Posted
: March 19, 2013
Results First Posted
: January 4, 2018
Last Update Posted
: February 5, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | March 15, 2013 | |||
First Posted Date ICMJE | March 19, 2013 | |||
Results First Submitted Date | December 4, 2017 | |||
Results First Posted Date | January 4, 2018 | |||
Last Update Posted Date | February 5, 2018 | |||
Actual Study Start Date ICMJE | April 18, 2013 | |||
Actual Primary Completion Date | July 12, 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change From Baseline in Percent Atheroma Volume at Week 78 [ Time Frame: Baseline and week 78 ] Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
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Original Primary Outcome Measures ICMJE |
Nominal change in PAV from baseline to 78 weeks post randomization, as determined by intravascular ultrasound (IVUS) [ Time Frame: 78 weeks ] | |||
Change History | Complete list of historical versions of study NCT01813422 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound | |||
Official Title ICMJE | A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization | |||
Brief Summary | This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Hypercholesterolemia | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
970 | |||
Original Estimated Enrollment ICMJE |
950 | |||
Actual Study Completion Date | July 29, 2016 | |||
Actual Primary Completion Date | July 12, 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Subjects must meet the following criteria at the qualifying coronary catheterization procedure:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 99 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01813422 | |||
Other Study ID Numbers ICMJE | 20120153 2012-004208-37 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Amgen | |||
Study Sponsor ICMJE | Amgen | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | January 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |